Code of Federal Regulations · Section
§ 864.5700 — Automated Platelet Aggregation System
21 C.F.R. § 864.5700
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(a) Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351